The introduction of biosimilars into clinical practice

Transcription

1 Commissioning Chemotherapy Services The introduction of biosimilars into clinical practice Jatinder Harchowal Chief Pharmacist / Clinical Director Royal Marsden NHS Foundation Trust Medicines lead for RM Partners The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

2 Objectives Background to Biosimilars use across NHSE biosimilar Rituximab project Experience and follow-up Questions The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

3 Commissioning Framework - Sep of the top 10 spend medicines are biologics Potential to realise savings of m / year by 2020/21 Aim for 90% of new patients to be prescribed best value biological medicine within 3 months of launch 80% of existing patients within 12 months

4 Variation in the uptake of previous Biosimilars in England The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

5 Biosimilar Rituximab first in haematology Learning from experience from other Biosimilars 160m spend (16/17 in NHSE) Opportunity to save 70m on cancer indications Opportunity with the initiative Use local & national expertise to drive NHSE wide change

6 Overview of the One of the recommendations of the National Cancer Strategy was to develop new models of care for cancer. In 2015 the was launched to test and fast-track innovative and new models of cancer care. The is made up of three systems: o North West and South West London (led by RM Partners) o Greater Manchester (led by the Christie) o West Essex North Central and North East London (led by UCLH) The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

7 The cancer vanguard medicines optimisation team o RM Partners led a joint piece of work with Sandoz o Development of a central repository of information for introduction of biosimilars: Identify and engage key clinical stakeholders FAQs etc Run education sessions Involve Patient groups Develop policies for introduction in local Trusts The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

8 A range of stakeholders we engaged with Clinical: Haematologists, Nursing, Pharmacy The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

9 A range of stakeholders to consider Clinical: Haematologists, Nursing, Pharmacy Pharmacy: Clinical, Purchasing, Formulary, E-prescribing The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

10 A range of stakeholders to consider Clinical: Haematologists, Nursing, Pharmacy Pharmacy: Clinical, Purchasing, Formulary, E-prescribing Trust: Formulary and D&TC, Finance The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

11 A range of stakeholders to consider Clinical: Haematologists, Nursing, Pharmacy Pharmacy: Clinical, Purchasing, Formulary, E-prescribing Trust: D&TC, Finance Professional groups: ESMO, BOPA, Lymphoma Groups The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

12 A range of stakeholders to consider Clinical: Haematologists, Nursing, Pharmacy Pharmacy: Clinical, Purchasing, Formulary, E-prescribing Trust: D&TC, Finance Professional groups: ESMO, BOPA, Lymphoma Groups Commissioners: Local and national (NHSE) - CQUINs The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

13 The critical step Staff education / Communication Delivered as part of vanguard project Dedicated classroom sessions for pharmacy, nursing and medical staff Assessed impact of education very positive! Don t underestimate the importance of this The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

14 The How The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

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17 Staff education / Communication The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

18 Variability is a fact of life Manufacturing changes can create variability in the biologic molecule Vezér B, Zrubka Z et al; CMRO, 2016, 32:

19 Staff education on how Biosimilars are developed The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

20 Biosimilars are highly similar Biosimilars are approved biologics.demonstrated to be highly similar to a reference product numerous batches / over many years European Medicines Agency (EMA). Guideline on similar biological medicinal products. CHMP/437/04 Rev 1/2014 [online]. Available from URL: [Accessed 2016 March 18]; US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 2015 [online] Available from URL: [Accessed 2016 March 18].

21 Biosimilars are nothing new Biosimilar human growth hormone approved in EU Biosimilar GCSF approved in EU Biosimilar GCSF first biosimilar product to surpass reference product usage Biosimilar etanercept approved in EU Biosimilar human growth hormone approved in Australia Biosimilar human growth hormone approved in EU Biosimilar human growth hormone approved in US Biosimilar human growth hormone approved in Japan & Canada Biosimilar infliximab approved in EU Biosimilar rituximab approved in EU Biosimilars are marketed in over 75 countries and now have over 250 million patient-days of experience 1 Throughout this period, the safety profile of biosimilars has been consistent with the reference products and the product class 2,3,4 Biosimilars are now in routine use in the NHS, particularly in rheumatology and gastroenterology Gascon P et al Support Care Cancer. 2013; 21(10): Romer et al Horm Res 2009; 72(6): For full adverse event profiles, please refer to Zarzio and Omnitrope SPCs available at:

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24 Patient Engagement co-created information Joint patient information with Lymphoma Association Switching patients were informed in advance, in writing We did not re-consent patients We did not change the consent process for new patients The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

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26 After the clinical and patient support. Trust approval Policy agreed across all 3 Vanguard sites MD, DTC Chair and Chief Pharmacist support Pharmacy Electronic prescribing systems updated Commissioner approval The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

27 Final Case for change to switch to a biosimilar rituximab. The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

28 Experience to date from RMH and UCLH Complete switch to Biosimilar Rituximab for all patients End of September 2017 in RMH and UCLH: 317 patients treated with biosimilar Rituximab 796 infusions Mainly grade 1 and 2 reactions in line with originator No practical problems noticed The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

29 Current rituximab use in RMH 80 No. of rituximab infusions given at RMH (apr17-oct17)* *excluding trial patients and subcutaneous doses Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 RITUXIMAB (MABTHERA) RITUXIMAB (TRUXIMA) The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

30 Branded & biosimilar rituximab spend in RMH 120, ,000 Monthly spend* on Rituximab at RMH Apr 16 - Oct 17 *NHS only Savings now > 60,000/month 80,000 60,000 40,000 20,000 0 RITUXIMAB (MABTHERA) RITUXIMAB (TRUXIMA) The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

31 Rituximab uptake nationally by region 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% North East London East of England South West East Midlands Yorks & Humber South East Coast South Central North West West Midlands National Rituximab IV - Biosimilar Uptake National uptake: 55% 20.0% 10.0% 0.0% Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

32 Biosimilars: Summary Biosimilars developed to be highly similar to their reference biologic Widespread support for switching to biosimilars - now Education and information on biosimilars remains key New commissioning guidance and CQUINs enablers Adoption will only succeed with multi-stakeholder approach

33 Reflections of the Approach Example of collaborative and system wide leadership All documents readily available on website Replicability of the approach Trastuzamab and Adalimumab Pace of delivery not possible without the joint working with Pharmaceutical Industry (non-promotional) The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

34 Acknowledgements Particular thanks to: Tim McCarthy, Principal Pharmacist, RMH Philip Murphy, Sandoz The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative

35 Questions? The is a partnership between Greater Manchester Innovation, RM Partners and UCLH Cancer Collaborative